PainNCT01834027
The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy
A study testing Jazz music and No music in people with Pain and Anxiety, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of music on patients after surgery in the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant emotional stress and anxiety which can include discomfort or pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- What is being tested?
- Jazz music and No music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective hysterectomy (laparoscopic or robotic)
- ASA 1 or 2
- Normotensive
- Normal heart rate
Who cannot join
- Patient does not wish to participate in the study
- Deaf or hearing impaired patients
- Ear deformities or abnormalities
- Pre-existing diagnosis of anxiety disorder, depression, substance abuse, or any other psychiatric diagnoses
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The purpose of this study is to investigate the effects of music on patients after surgery in the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant emotional stress and anxiety which can include discomfort or pain. Music therapy has proven to be a useful adjuvant in various inpatient and outpatient settings by providing a relaxing effect that decreases heart rate, blood pressure, and hormonal measures of stress. It has been shown that classical music can cause physiological and psychological differences in patient outcomes, but few studies have looked specifically at effects of jazz music. Some have argued that jazz may be too involved to provide the same relaxed state as classical music, but this may be due in part to the type of jazz played for the patient. It is our hypothesis that slow jazz music by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc. will reduce measures of stress and anxiety in patients in the PACU following surgery for hysterectomy (laparoscopic or robotic) to a greater extent than the control group. Jazz music or "no music" will be played through headphones to participants in the study post-surgically while they are in the PACU and measures of stress, anxiety, and pain will be monitored.
Read the detailed description
- Patients will be identified the morning of surgery from the operating room schedule.
- The patients will be randomized to two groups: jazz music or no music.
- Head phones will be applied to all patients included in the study; in one group jazz music will be provided through the headphones. The second group no music will be played.
- Blood pressure will be monitored by a non-invasive blood pressure cuff at 5 minute intervals throughout the patient's stay in the PACU.
- Heart rate will be measured, using a pulse oximeter, at the same intervals as blood pressure.
- Before the patient leaves the PACU, she will be asked to rate her perception of her levels of pain and anxiety on scales that use a numeric scale of 1-10. The primary variable outcomes are: heart rate and mean blood pressure. Secondary outcomes include: perceived pain, anxiety, and level of relaxation.
- headphones will be used to deliver one of the following sounds to the patients: 1) jazz music (BPM<100) by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc.; or 2) no music providing.
- Being tested
- Jazz music, No music
- Keywords
- music, stress, anxiety, post-surgical, pain
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jazz musicBehavioural
Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit.
No musicBehavioural
Also called control group
In this group no music will be played in PACU
| Study group | Role | What they receive |
|---|---|---|
| Jazz music | Experimental | Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit. Receives: Behavioral: Jazz music |
| No music | Active comparator | The patients in this group with have headphones but no music will be played. Receives: Behavioral: No music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate From Baseline on Arrival in PACU
Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry
Measured: 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU
Secondary outcomes (3)
Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU
Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated.
Measured: Once, at 30 minutes after the patient entered the PACU
Mean Difference in Patient's Perception of Pain From Baseline
The patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated.
Measured: 10, 20 , and 30 minutes after baseline measurement
Mean Blood Pressure
non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Vaida, Penn State University
- Investigators
- Sonia Vaida, MD, Principal investigator, Penn State UniversityJansie Prozesky, MD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834027
- Sponsor's protocol ID
- IRB 40925
- Status last verified
- Mar 2016
- First submitted
- 30 Nov 2012
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy
- ClinicalTrials.gov ID
- NCT01834027
- Acronym / sponsor ID
- IRB 40925
- Keywords
- music, stress, anxiety, post-surgical, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Posted 22 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of music on patients after surgery in the Post Anesthesia Care Unit (PACU). For many patients, surgery creates significant emotional stress and anxiety which can include discomfort or pain. Music therapy has proven to be a useful adjuvant in various inpatient and outpatient settings by providing a relaxing effect that decreases heart rate, blood pressure, and hormonal measures of stress. It has been shown that classical music can cause physiological and psychological differences in patient outcomes, but few studies have looked specifically at effects of jazz music. Some have argued that jazz may be too involved to provide the same relaxed state as classical music, but this may be due in part to the type of jazz played for the patient. It is our hypothesis that slow jazz music by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc. will reduce measures of stress and anxiety in patients in the PACU following surgery for hysterectomy (laparoscopic or robotic) to a greater extent than the control group. Jazz music or "no music" will be played through headphones to participants in the study post-surgically while they are in the PACU and measures of stress, anxiety, and pain will be monitored.
Detailed description
- Patients will be identified the morning of surgery from the operating room schedule.
- The patients will be randomized to two groups: jazz music or no music.
- Head phones will be applied to all patients included in the study; in one group jazz music will be provided through the headphones. The second group no music will be played.
- Blood pressure will be monitored by a non-invasive blood pressure cuff at 5 minute intervals throughout the patient's stay in the PACU.
- Heart rate will be measured, using a pulse oximeter, at the same intervals as blood pressure.
- Before the patient leaves the PACU, she will be asked to rate her perception of her levels of pain and anxiety on scales that use a numeric scale of 1-10. The primary variable outcomes are: heart rate and mean blood pressure. Secondary outcomes include: perceived pain, anxiety, and level of relaxation.
- headphones will be used to deliver one of the following sounds to the patients: 1) jazz music (BPM<100) by artists including Miles Davis, Ella Fitzgerald, Diana Krall, Dave Brubeck, etc.; or 2) no music providing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jazz music | Experimental | Behavioral: Jazz musicJazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit. |
| No music | Active comparator | Behavioral: No musicThe patients in this group with have headphones but no music will be played. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing elective hysterectomy (laparoscopic or robotic)
- ASA 1 or 2
- Normotensive
- Normal heart rate
Key exclusion criteria (4 listed)
- Patient does not wish to participate in the study
- Deaf or hearing impaired patients
- Ear deformities or abnormalities
- Pre-existing diagnosis of anxiety disorder, depression, substance abuse, or any other psychiatric diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jazz musicJazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit. | Behavioural | Jazz music |
| No musicAlso: control groupIn this group no music will be played in PACU | Behavioural | No music |
Primary outcome
Change in Heart Rate From Baseline on Arrival in PACU
Time frame: 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU
Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry
3 secondary outcomes
Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU
Time frame: Once, at 30 minutes after the patient entered the PACU
Mean Difference in Patient's Perception of Pain From Baseline
Time frame: 10, 20 , and 30 minutes after baseline measurement
Mean Blood Pressure
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Vaida, MD principal investigator
Penn State University
Jansie Prozesky, MD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jazz music and No music in people with Pain and Anxiety, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate From Baseline on Arrival in PACU (time frame: 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.